GLP Toxicokinetics
Build confidence in safety assessments with GLP-compliant toxicokinetics that connect exposure data to meaningful development decisions.
What is Toxicokinetics?
Toxicokinetics (TK) evaluates the relationship between drug exposure and observed toxic effects, helping to establish the No Observed Adverse Effect Level (NOAEL)—a critical benchmark for selecting safe and effective clinical doses. While pharmacokinetics (PK) typically focuses on therapeutic exposures, TK extends those principles to higher, potentially toxic concentrations to understand accumulation, changes in clearance and exposure, and dose-limiting exposure thresholds.
GLP-compliant TK studies provide regulatory data required to support IND, NDA, and BLA submissions, while non-GLP exploratory dose range finding studies are appropriate earlier in development to save time and cost. In both cases, TK provides the foundation for linking preclinical safety based on exposure to first-in-human trial design and critical exposure stopping criteria.
Core GLP Toxicokinetics Capabilities
We design and execute TK studies across multiple species, integrating toxicology, bioanalysis, clinical, and regulatory expertise to ensure your data is both compliant and actionable.
TK Study Design & Execution
Single-dose and repeat-dose exposure assessments tailored to your compound and development stage.
Systemic Exposure & Dose-Proportionality
Evaluate drug accumulation, clearance, and dose-proportionality to support safety and dosing decisions.
Species Comparison & Translation to FIH Dosing
Bridge preclinical results to clinical expectations with translational PK analysis.
GLP & Non-GLP
High-quality data generation using LC-MS/MS, ligand-binding assays, and other validated approaches.
Regulatory-Compliant TK Reports
Robust reporting that meets FDA, EMA, and ICH requirements, ready to support IND, NDA, and BLA submissions.
Choosing a GLP Toxicokinetics CRO
Selecting the right GLP toxicokinetics CRO requires expertise that goes beyond calculating PK parameters. An experienced partner should understand how to evaluate systemic exposure within the context of a toxicology study and translate parameters such as AUC, Cmax, and Tmax into meaningful insights for safety assessment and clinical development.
Look for a CRO with experience in GLP toxicokinetic analysis, interpretation, and reporting for IND-enabling and other regulatory studies. The right partner should be able to evaluate exposure across dose levels, assess accumulation and dose proportionality, and interpret TK findings alongside observed safety outcomes.
Why Choose Xyzagen for GLP Toxicokinetics?
Unlike larger CROs, where TK teams may not be engaged until bioanalytical data are available, Xyzagen brings pharmacokinetic expertise into the process early. Our scientists can advise on study design, bioanalytical method requirements, dose solution confirmation, and optimal sampling time points to help ensure the resulting data answer the right questions.
This hands-on, collaborative approach reflects the same philosophy behind our First-in-Rat® and First-in-Mouse® programs: design studies with the end decision in mind. By considering TK strategy from the start, we help sponsors maximize the value of their toxicology studies and generate meaningful exposure data to support safer, more informed first-in-human development.
Partner with Xyzagen
Need GLP Toxicokinetics support? Contact us today to discuss your program and learn how Xyzagen can deliver the insights you need for confident decision-making.
